ComPel Single Wrap 27666302

GUDID 00634916016543

COMPEL SINGLE WRAP 36X36 2PLY - 2 PLY MERROWED-CC BLUE THR

STANDARD TEXTILE CO., INC.

Sterilization packaging, reusable

• Primary Device ID: 00634916016543
• NIH Device Record Key: 89bd97d5-d50d-4b47-93ae-058d7deb29e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ComPel Single Wrap
• Version Model Number: 27666302
• Catalog Number: 27666302
• Company DUNS: 006999858
• Company Name: STANDARD TEXTILE CO., INC.
• Device Count: 72
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634916016543 [Primary]
GS1	10634916016543 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K923408

FDA Product Code

• FRG: Wrap, Sterilization

Sterilization

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

[00634916016543]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00634916016543]

Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-01-29

On-Brand Devices [ComPel Single Wrap]

• 00634916295092: COMPEL SINGLE WRAP 2PLY 30X30 - RM (98 8282) USE: 27666282
• 00634916295085: COMPEL SINGLE WRAP KAUM 45X45 - RM (98 8282) USE: 27666502
• 00634916295078: COMPEL SINGLE WRAP KAUM 24X24 - RM (98 8282) USE: 27666202
• 00634916179958: COMPEL SINGLE WRAP KAUM 45X45 - RM (98 7647) USE: 27666502
• 00634916179941: COMPEL SINGLE WRAP KAUM 36X36 - RM (98 7647) USE: 27666302
• 00634916179934: COMPEL SINGLE WRAP KAUM 24X24 - RM (98 7647) USE: 27666202
• 00634916179927: COMPEL SINGLE WRAP KAUM 18X18 - RM (98 7647) USE: 27666152
• 00634916179910: COMPEL SINGLE WRAP KAUM 54X54 - RM (98 7647) USE: 27666602
• 00634916103236: COMPEL SINGLE WRAP KAUM 45X45 - RM (98 7733) USE: 27666502
• 00634916103106: COMPEL SINGLE WRAP KAUM 45X45 - RM (98 7733) USE: 27666502
• 00634916101713: COMPEL WRAPPER KAUM 36X36 2PLY - RM (98 7733) USE: 27666302
• 00634916101706: COMPEL WRAPPER KAUM 30X30 2PLY - RM (98 7733) USE: 27666282
• 00634916080018: COMPEL SINGLE WRAP 45X45 KAUM - RM(98 7647)2-KAUM'USE:27666502
• 00634916079982: COMPEL SINGLE WRAP 54X54 KAUM - RM(98 7647)2-KAUM'USE:27666602
• 00634916074123: COMPEL SINGLE WRAP 30X30 2-KAUMS - RM(98 7647)2-KAUM'USE:27666282
• 00634916027624: COMPEL SINGLE WRAP 2PLY 45X80 BL - MEROWED-CC LAVENDER/WHITE THR
• 00634916023671: COMPEL SINGLE WRAP 45X45 KAUM - RM (98 6749) USE: 27666502
• 00634916023664: COMPEL SINGLE WRAP 30X30 KAUM - RM (98 6749) USE: 27666282
• 00634916023657: COMPEL SINGLE WRAP 24X24 KAUM - RM (98 6749) USE: 27666202
• 00634916016680: COMPEL SINGLE WRAP 54X72 2PLY - 54X72 MERROWED-CC SALMON THR
• 00634916016673: COMPEL SINGLE WRAP 54X54 2PLY - 54X54 MERROWED-CC BLUE THR
• 00634916016666: COMPEL SINGLE WRAP 45X45 2PL - 45X45 MEROWED-CC YELLOW THR
• 00634916016543: COMPEL SINGLE WRAP 36X36 2PLY - 2 PLY MERROWED-CC BLUE THR
• 00634916016536: COMPEL SINGLE WRAP 30X30 2PLY - 2 PLY MERROWED-CC PINK THR
• 00634916016529: COMPEL SINGLE WRAP 24X24 2PLY - 2PLY MERROWED-CC GREEN THR
• 00634916016512: COMPEL SINGLE WRAP 18X18 2PLY - 18X18 MERROWED-CC LAVENDER THR