AccessGUDID - DEVICE: Silicone Strip (10871321001567)

GUDID

Device Identifier (DI) Information

Brand Name: Silicone Strip
Version or Model: S 2967
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Labtician Ophthalmics, Inc

Primary DI Number: 10871321001567
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 248911026 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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:	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?
15794	Scleral buckling device, bioabsorbable	A bioabsorbable device intended to be implanted on the sclera to compress the eye (scleral buckling) for the surgical treatment of retinal detachment.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HQJ	Implant, Absorbable, (Scleral Buckling Methods)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K875014	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9ec0565f-fade-45f0-ba6b-4a85bf301cab
Public Version Date: December 22, 2021
Public Version Number: 5
DI Record Publish Date: October 09, 2015

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: 00871321000426 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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 905-829-0055
Email: philcuscuna@labtician.com

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