AccessGUDID - DEVICE: Silktoe Spacer (08057717550863)

GUDID

Device Identifier (DI) Information

Brand Name: Silktoe Spacer
Version or Model: SIZE 40 LEFT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BRDNEWP4040L
Company Name: BRM EXTREMITIES SRL

Primary DI Number: 08057717550863
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 435126746 *Terms of Use

Device Description: No description.

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
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?
33700	Total metatarsophalangeal joint prosthesis, one-piece	An implantable device designed to replace the metatarsophalangeal (MTP) joint(s) of the foot (toe). The device is made of a single piece of silicone elastomer. It is is intended to treat degenerative or traumatic arthritis, hallux valgus, hallus rigidus, and/or an unstable or painful MTP joint.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWH	Prosthesis, Toe, Constrained, Polymer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191966	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Special Storage Condition, Specify: Store at room temperature, keep dry and away from humidity and direct sources of light and heat.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 40 LEFT

Device Record Status

Public Device Record Key: 43d3aeb5-cc3d-4930-9f94-d61d2467fea1
Public Version Date: October 25, 2021
Public Version Number: 1
DI Record Publish Date: October 17, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +3903411693087
Email: info@brm-extremities.com

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