AccessGUDID - DEVICE: Pectoralis Implant (B049ACP22RS0)

GUDID

Device Identifier (DI) Information

Brand Name: Pectoralis Implant
Version or Model: ACP 2-2 R S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ACP 2-2 R S
Company Name: Hanson Medical, Inc.

Primary DI Number: B049ACP22RS0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058759296 *Terms of Use

Device Description: Non-sterile, silicone, pectoralis implant, right, sizer.

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?
48162	Pectoral implant, non-sterile	A non-sterile implantable device designed for cosmetic augmentation (submuscular implantation) or reconstruction (e.g., to correct injuries/congenital absence) of the pectoral muscle(s). It is a preshaped (e.g., convex/concave oval-shaped) device typically composed of silicone elastomer. It is intended to be sterilized prior to use.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
MIC	Implant, Muscle, Pectoralis

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K973729	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 6f416581-eb3f-4482-bec3-e283e99da322
Public Version Date: July 18, 2023
Public Version Number: 5
DI Record Publish Date: October 14, 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: 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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1(800)771-2215
Email: erik@hansonmedical.com

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