STERIMED, INC. 1010360B5454BA

GUDID 00815588025822

STERISHEET NW 60B 54 X 54

STERIMED INC.

Sterilization packaging, single-use

• Primary Device ID: 00815588025822
• NIH Device Record Key: c3a57fd5-51f0-4a74-b4c6-093cd32470d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERIMED, INC.
• Version Model Number: 1010360B5454BA
• Catalog Number: 1010360B5454BA
• Company DUNS: 182052670
• Company Name: STERIMED INC.
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(843)388-8080
• Email: michelle.pendergraph@sterimed.us
• Phone: +1(843)388-8080
• Email: michelle.pendergraph@sterimed.us
• Phone: +1(843)388-8080
• Email: michelle.pendergraph@sterimed.us
• Phone: +1(843)388-8080
• Email: michelle.pendergraph@sterimed.us
• Phone: +1(843)388-8080
• Email: michelle.pendergraph@sterimed.us
• Phone: +1(843)388-8080
• Email: michelle.pendergraph@sterimed.us
• Phone: +1(843)388-8080
• Email: michelle.pendergraph@sterimed.us
• Phone: +1(843)388-8080
• Email: michelle.pendergraph@sterimed.us
• Phone: +1(843)388-8080
• Email: michelle.pendergraph@sterimed.us
• Phone: +1(843)388-8080
• Email: michelle.pendergraph@sterimed.us
• Phone: +1(843)388-8080
• Email: michelle.pendergraph@sterimed.us
• Phone: +1(843)388-8080
• Email: michelle.pendergraph@sterimed.us
• Phone: +1(843)388-8080
• Email: michelle.pendergraph@sterimed.us
• Phone: +1(843)388-8080
• Email: michelle.pendergraph@sterimed.us
• Phone: +1(843)388-8080
• Email: michelle.pendergraph@sterimed.us
• Phone: +1(843)388-8080
• Email: michelle.pendergraph@sterimed.us
• Phone: +1(843)388-8080
• Email: michelle.pendergraph@sterimed.us
• Phone: +1(843)388-8080
• Email: michelle.pendergraph@sterimed.us
• Phone: +1(843)388-8080
• Email: michelle.pendergraph@sterimed.us
• Phone: +1(843)388-8080
• Email: michelle.pendergraph@sterimed.us
• Phone: +1(843)388-8080
• Email: michelle.pendergraph@sterimed.us
• Phone: +1(843)388-8080
• Email: michelle.pendergraph@sterimed.us
• Phone: +1(843)388-8080
• Email: michelle.pendergraph@sterimed.us
• Phone: +1(843)388-8080
• Email: michelle.pendergraph@sterimed.us
• Phone: +1(843)388-8080
• Email: michelle.pendergraph@sterimed.us
• Phone: +1(843)388-8080
• Email: michelle.pendergraph@sterimed.us
• Phone: +1(843)388-8080
• Email: michelle.pendergraph@sterimed.us
• Phone: +1(843)388-8080
• Email: michelle.pendergraph@sterimed.us
• Phone: +1(843)388-8080
• Email: michelle.pendergraph@sterimed.us
• Phone: +1(843)388-8080
• Email: michelle.pendergraph@sterimed.us
• Phone: +1(843)388-8080
• Email: michelle.pendergraph@sterimed.us
• Phone: +1(843)388-8080
• Email: michelle.pendergraph@sterimed.us
• Phone: +1(843)388-8080
• Email: michelle.pendergraph@sterimed.us

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815588025815 [Primary]
GS1	00815588025822 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K931202

FDA Product Code

• FRG: Wrap, sterilization

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-02
• Device Publish Date: 2021-03-25

On-Brand Devices [STERIMED, INC.]

• 00815588025570: 260I 36X36,250
• 00815588025563: 260I 36X36,250
• 00815588025556: 260I 36X36 P/N 490 250
• 00815588025549: 260I 30X30,250
• 00815588025532: 260I 30X30,250
• 00815588025525: 260I 30X30 P/N 489 500
• 00815588025518: 260I 24X24,500
• 00815588025501: 260I 24X24,500
• 00815588025495: 260I 24X24 P/N 488 500
• 00815588025488: 260I 20X20,500
• 00815588025471: 260I 20X20,500
• 00815588025464: 260I 20X20 P/N 487 500
• 00815588025457: 260I 18X18,500
• 00815588025440: 260I 18X18,500
• 00815588025433: 260I 15X15,1000
• 00815588025426: 260I 15X15,1000
• 00815588025419: 260I 15X15 P/N 486 1000
• 00815588025402: 260I 12X12,1000
• 00815588025396: 260I 12X12,1000
• 00815588025099: 260I 36X36,5000 CS/GAYLORD
• 00815588025082: 260I 30X30,9000/CS-GAYLORD
• 00815588025075: 260I 24X24, 15000/CS-GAYLORD
• 00815588025068: 260I 20X20,20000/CS-GAYLORD
• 00815588025051: 260I 18X18, 26000/CS-GAYLORD
• 00815588025044: 260I 15X15, 40000/CS-GAYLORD
• 00815588025037: 260I 12X12, 50000/CS -GAYLORD
• 00815588025020: 260I 54X72,100
• 00815588025013: 260I 54X72,100
• 00815588025006: 260I 54X54,100
• 00815588024993: 260I 54X54,100
• 00815588024986: 260I 48X48,100
• 00815588024979: 260I 48X48,100
• 00815588024962: 260I 45X45,250
• 00815588024955: 260I 45X45,250
• 00815588024948: 260I 40X40,250
• 00815588024931: 260I 40X40,250
• 00815588022654: 52 24X24,10000/CS-GAYLORD
• 00815588025808: STERISHEET NW 78B 24 X 24
• 00815588025785: STERISHEET RF 60I 36 X 36
• 00815588025754: STERISHEET RF 60I 30 X 30
• 00815588025747: STERISHEET RF 60I 20 X 20
• 00815588025723: STERISHEET NW 60B 40 X 40
• 00815588025709: STERISHEET NW 78B 36 X 36
• 00815588025686: STERISHEET NW 78B 48 X 48
• 00815588025662: STERISHEET RF 60I 54 X 72
• 00815588025648: STERISHEET RF 60I 54 X 54
• 00815588025624: STERISHEET RF 60I 48 X 48
• 00815588025600: STERISHEET CE 60B 40 X 40
• 00815588025846: STERISHEET NW 60B 36 X 36
• 00815588025822: STERISHEET NW 60B 54 X 54