Arthrex Nerve Wrap ABS-6025W

GUDID 00813954027357

Collagen Nerve Protector

COLLAGEN MATRIX, INC.

Nerve guide, animal-derived
Primary Device ID00813954027357
NIH Device Record Key28c45c04-5fb4-459b-8dfb-0c5a15e5bd22
Commercial Distribution StatusIn Commercial Distribution
Brand NameArthrex Nerve Wrap
Version Model NumberABS-6025W
Catalog NumberABS-6025W
Company DUNS176262442
Company NameCOLLAGEN MATRIX, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(800) 934-4404
EmailCustomer_Service@Arthrex.com
Phone(800) 934-4404
EmailCustomer_Service@Arthrex.com
Phone(800) 934-4404
EmailCustomer_Service@Arthrex.com
Phone(800) 934-4404
EmailCustomer_Service@Arthrex.com
Phone(800) 934-4404
EmailCustomer_Service@Arthrex.com
Phone(800) 934-4404
EmailCustomer_Service@Arthrex.com
Phone(800) 934-4404
EmailCustomer_Service@Arthrex.com
Phone(800) 934-4404
EmailCustomer_Service@Arthrex.com
Phone(800) 934-4404
EmailCustomer_Service@Arthrex.com
Phone(800) 934-4404
EmailCustomer_Service@Arthrex.com
Phone(800) 934-4404
EmailCustomer_Service@Arthrex.com
Phone(800) 934-4404
EmailCustomer_Service@Arthrex.com
Phone(800) 934-4404
EmailCustomer_Service@Arthrex.com
Phone(800) 934-4404
EmailCustomer_Service@Arthrex.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100813954027357 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JXICuff, Nerve

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-04
Device Publish Date2025-07-25

On-Brand Devices [Arthrex Nerve Wrap]

00813954027388Collagen Nerve Protector
00813954027371Collagen Nerve Protector
00813954027364Collagen Nerve Protector
00813954027357Collagen Nerve Protector
00813954027340Collagen Nerve Protector
00813954027333Collagen Nerve Protector

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.