WrapPel Wrapper 2776N502

GUDID 00634916032581

STERILE WRAP WRAPPEL 45X45 - 1PLY MEROWED-CC WHITE THREAD

STANDARD TEXTILE CO., INC.

Sterilization packaging, reusable Sterilization packaging, reusable

• Primary Device ID: 00634916032581
• NIH Device Record Key: a1f7a790-126e-4628-bcfd-5788a3962341
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WrapPel Wrapper
• Version Model Number: 2776N502
• Catalog Number: 2776N502
• 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	00634916032581 [Primary]
GS1	10634916032581 [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

[00634916032581]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00634916032581]

Moist Heat or Steam Sterilization;Ethylene Oxide

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 [WrapPel Wrapper]

• 00634916284287: WRAP MINI BARRIER GRN 22X23.5 - 1PLY WRAPPEL GREEN (SR 17222)
• 00634916284270: WRAP SMALL BARRIER GRN 34X37.5 - 1PLY WRAPPEL GREEN (SR 17223)
• 00634916276053: WRAPPER WRAPPEL 70X70 BLUE - 1PLY MERROWED-CC BLACK THRD
• 00634916122916: STERILIZATION WRAP 18X15 BLUE - WRAPPEL MERROWED LT BLUE THRD
• 00634916103946: WRAPPER WRAPPEL 36X36 (FIN SZ) - 36X36 MERROWED-CC BLUE THREAD
• 00634916103939: WRAPPER WRAPPEL 45X45 (FIN SZ) - 45X45 MERROWED-CC WHITE THREAD
• 00634916101720: STERILE WRAP WrapPel KAUM 54X54 - RM (98 7733) USE: 27766602
• 00634916076097: STERILE WRAP WRPL 24X24 KAUM - RM (98-7507) USE: 27766202
• 00634916069280: WRAPPER WRAPPEL 54X54 - 1PLY MERROWED CC BLUE THRD
• 00634916056273: WRAPPER WRAPPEL BLUE 60X70 - MERROWED-CC BLK THRD (SR12774)
• 00634916032581: STERILE WRAP WRAPPEL 45X45 - 1PLY MEROWED-CC WHITE THREAD
• 00634916032574: STERILE WRAP WRAPPEL 36X36 - 1PLY MERROWED-CC BLUE THR
• 00634916032567: STERILE WRAP WRAPPEL 30X30 - 1 PLY MERROWED-CC PINK THR
• 00634916032550: STERILE WRAP WRAPPEL 24X24 - 1PLY MERROWED-CC GREEN THR
• 00634916001396: STERILE WRAP 54X72 WRAPPEL 1PL - 54X72 MERROWED-CC SALMON THR
• 00634916001389: STERILE WRAP WRAPPEL 54X54 1PL - 54X54 MERROWED-CC BLUE THR
• 00634916001372: STERILE WRAP WRAPPEL 45X45 1PL - 45X45 MEROWED-CC WHITE THR
• 00634916001365: STERILE WRAP 36X36 WRAPPEL 1PL - 1PLY MERROWED-CC BLUE THR
• 00634916001358: STERILE WRAP WRAPPEL 30X30 1PL - 1 PLY MERROWED-CC PINK THR
• 00634916001341: STERILE WRAP 24X24 WRAPEL 1PL - 1PLY MERROWED-CC GREEN THR
• 00634916001334: STERILE WRAP 18X18 WRAPPEL 1PL - 18X18 MERROWED-CC LAVENDER THR
• 00634916001327: STERILE WRAP WRAPPEL 12X12 1PL - 12X12 MERROWED-CC BLUE THR