FDA.report

Millennium

Primary DI
00190776164331
Brand
Millennium
Company
AVALIGN TECHNOLOGIES, INC.
Model
1-SGM
Device description
OHSU Customer Vaginoplasty Skin Graft Mold
Published
2021-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FZWEXPANDER, SURGICAL, SKIN GRAFT

Product Code Classifications

CodeDeviceSpecialtyClass
FZWExpander, Surgical, Skin GraftGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190776164331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776164331001907761643311907761643310190776164331

GMDN Terms

TermDefinition
Skin graft mesherA manual surgical device used to perforate a skin graft (a section of donor skin from another part of the patient's body) with a pattern of lacerations (cuts) before the skin is grafted to the area being treated on the patient. The skin may be placed on a skin graft carrier to better support it and will typically be run through an instrument with a row of cutting wheels, or be subjected to a rolling drum with a handle and cutting blades, to improve graft stretch and permeability and facilitate graft conformity and healing. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(877)289-1096product.questions@avalign.com

Regulatory Flags

DUNS number
792528510
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00190776417895Millennium72-53030126C2026-03-23
00190776417901Millennium72-3280326I2026-03-23
00190776417918Millennium72-235613LH2026-03-23
00190776417925Millennium72-3752532026-03-23
00190776417932Millennium100-S03681TRS2026-03-23
00190776417949Millennium72-235633LH2026-03-23
00190776417956Millennium72-5225532B2026-03-23
00190776417963Millennium72-2407032026-03-23
00190776417970Millennium72-4071222026-03-23
00190776417987Millennium1-2236262026-03-23
00190776417994Millennium1-1281562026-03-23
00190776418007Millennium1-OP3702026-03-23
00190776418014Millennium1-7063104R2026-03-23
00190776418021Millennium72-3160021FSYR2026-03-23
00190776418038Millennium1-8207-92026-03-23
00190776418045Millennium1-161762026-03-23
00190776418052Millennium1-3011172026-03-23
00190776418069Millennium1-4301632026-03-23
00190776418076Millennium72-31578452026-03-23
00190776418267Millennium72-24026202026-03-23

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04049197024686RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFZW2024-10-02
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04049197024709RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFZW2024-10-02
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00855638007149Brennen Skin Graft MesherSTELLEN MEDICAL, LLCFZW2022-08-10
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