AccessGUDID - DEVICE: ContexGel.sleeve (04048817622691)

GUDID

Device Identifier (DI) Information

Brand Name: ContexGel.sleeve
Version or Model: 30L10/M
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 30L10/M
Company Name: Streifeneder ortho.production GmbH

Primary DI Number: 04048817622691
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 317931954 *Terms of Use

Device Description: ContexGel.sleeve, anthracite, knee sleeve, size M, length: 37 cm, one-piece knit cover, antibacterial finish

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
41536	External limb prosthesis socket liner	A flexible device designed to be fitted inside the socket of an external upper or lower limb prosthesis to form an interface between the socket and the residual limb; it is intended to enable the residual limb to optimally fit the socket by coupling the two together mechanically and/or by pressure differential. It may be made of various textile or synthetic polymer materials (e.g., silicone, thermoplastic elastomer, polyurethane).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ISS	Prosthesis, Thigh Socket, External Component

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 30L10/S: size S, length: 37 cm, dist.: 15-23 cm, prox.: 23-35 cm
Device Size Text, specify: 30L10/M: size M, length: 37 cm, dist.: 21-31 cm, prox.: 29-44 cm
Device Size Text, specify: 30L10/L: size L, length: 38,5 cm, dist.: 28-43 cm, prox.: 36-52 cm
Device Size Text, specify: 30L10/XL: size XL, length: 38,5 cm, dist.: 34-48 cm, prox.: 42-58 cm
Device Size Text, specify: 30L10/XXL: size XXL, length: 38,5 cm, dist.: 38-52 cm, prox.: 43-64 cm

Device Record Status

Public Device Record Key: cde19cf8-c884-4173-9c54-96ba77faf0e3
Public Version Date: November 11, 2020
Public Version Number: 1
DI Record Publish Date: November 03, 2020