SIENTRA Calf Implant

Basic Information

• Brand Name: SIENTRA Calf Implant
• Primary DI: 00812790022953
• Version / Model: 402-270U
• Catalog Number: 402-270U
• Company Name: Sientra, Inc.
• Labeler DUNS: 010209877
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-23
• Public Version: 6
• Public Version Date: 2023-10-25
• Public Version Status: Update
• Public Device Record Key: 37885733-8850-4dd9-a781-6af1983e8ae1
• Distribution End Date: 2022-06-13

Device Description

Calf Implant, Silicone Elastomer, Symmetrical, Smooth, 105 cc

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MIB	Elastomer, Silicone Block	Ear, Nose, Throat	874.3620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45230	Silicone-block tissue reconstructive material	A non-sterile, solid chunk of silicone elastomer typically modified to suit the patient anatomy and implanted, after sterilization, for tissue reconstruction during a surgical procedure. The device is typically available as a cube with a rectangular cross-section or with curved surfaces. It may be carved or trimmed into different sizes and shapes for various reconstructive or cosmetic plastic surgery procedures that involve soft-tissue or bone augmentation, or the formation of prosthetic implants (e.g., chin or malar). This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812790022953	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K974480	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Volume: 105 cc