AccessGUDID - DEVICE: PureForm (00850987007079)

GUDID

Device Identifier (DI) Information

Brand Name: PureForm
Version or Model: 2NDP01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2NDP01
Company Name: SURGICAL TECHNOLOGY LABORATORIES INC

Primary DI Number: 00850987007079
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080380106 *Terms of Use

Device Description: "2NDP01 PureForm 2mm Pointed Nasal Dorsum - Small"

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?
31038	Nasal cartilage support implant, non-bioabsorbable	A non-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. It is a shaped device made of synthetic polymer materials (e.g., solid silicone rubber).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FZE	Prosthesis, Nose, Internal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K091011	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: 690a9489-3cef-45de-b1ae-5a474766d152
Public Version Date: March 05, 2024
Public Version Number: 4
DI Record Publish Date: September 24, 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
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: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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