AccessGUDID - DEVICE: LATERA (00857037006044)

GUDID

Device Identifier (DI) Information

Brand Name: LATERA
Version or Model: LATANI02
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: STRYKER CORPORATION

Primary DI Number: 00857037006044
Issuing Agency: GS1
Commercial Distribution End Date: September 18, 2020
Device Count: 2
Labeler D-U-N-S® Number*: 196548481 *Terms of Use

Device Description: Absorbable Nasal Implant

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:	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?
62157	Nasal cartilage support implant, bioabsorbable	A bioabsorbable device intended to be implanted beneath the skin of the nose (e.g., between the nasal mucosa and the cartilage) to augment or restore the cosmetic appearance and/or function of the nose by providing structural support to the cartilage to prevent nasal obstruction. It is a shaped device made of synthetic polymer materials [e.g., poly(L-lactide-co-D, L-lactide)] designed to gradually disintegrate following implantation. Dedicated devices intended to assist implantation through puncture of mucosal tissues may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NHB	Polymer, Ear, Nose And Throat, Synthetic, Absorbable

FDA Premarket Submission

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

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
Storage Environment Temperature: less than 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5ffa80ff-9d39-405d-a8d8-1bf96e199c05
Public Version Date: May 29, 2025
Public Version Number: 8
DI Record Publish Date: July 21, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00857037006969	6	00857037006044	2020-09-18	Not in Commercial Distribution

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 00857037006068 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

[?]

No Customer Contact currently defined

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