FDA.reportPublic FDA data

Avalign

Primary DI
00190776250669
Brand
Avalign
Company
AVALIGN TECHNOLOGIES, INC.
Model
VM57-6261
Device description
Braun-Stadler
Published
2023-06-23
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HDKSCISSORS, EPISIOTOMY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDKScissors, EpisiotomyObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776250669PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776250669001907762506691907762506690190776250669

GMDN Terms#

Term, Definition table
TermDefinition
Episiotomy scissors, reusableA hand-held, manual, obstetrical, surgical instrument intended to cut the outlet of the vagina in childbirth so as to facilitate the birth of the child (also known as perineotomy). It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and is available in various designs and sizes; the blades are typically angled, have different shapes, and may be serrated. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
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 DI, Brand, Model table
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049047003205GimmiGimmi GmbHHDK2025-04-22
04049047003212GimmiGimmi GmbHHDK2025-04-22
04049047003229GimmiGimmi GmbHHDK2025-04-22
04049047679844GimmiGimmi GmbHHDK2025-04-22
04049047679851GimmiGimmi GmbHHDK2025-04-22
00840183526207BR Surgical, LLCBR Surgical, LLCHDK2024-03-28
G586OB6441260Novo SurgicalNOVO SURGICAL, INC.HDK2023-12-18
G586OB96442290Novo SurgicalNOVO SURGICAL, INC.HDK2023-12-18
00190776050337AvalignAvalign Technologies, Inc.HDK2023-09-28
00190776250621AvalignAvalign Technologies, Inc.HDK2023-09-28
07898506853847QuinelatoSchobell Industrial LtdaHDK2023-07-11
00840183513542BR Surgical, LLCBR Surgical, LLCHDK2023-04-14
54026704792103PILLINGTELEFLEX INCORPORATEDHDK2022-12-08
00842331161261Novo Surgical Inc. NOVO SURGICAL, INC.HDK2022-11-13
00842331167171Novo Surgical Inc. NOVO SURGICAL, INC.HDK2022-11-13
00842331171772Novo Surgical Inc. NOVO SURGICAL, INC.HDK2022-11-13
00887482024171Symmetry Surgical®SYMMETRY SURGICAL INC.HDK2022-09-21
00887482039465Symmetry Surgical®SYMMETRY SURGICAL INC.HDK2022-09-21
00887482039472Symmetry Surgical®SYMMETRY SURGICAL INC.HDK2022-09-21
00887482018644Symmetry Surgical®SYMMETRY SURGICAL INC.HDK2022-08-23
00190660157180Ambler SurgicalAMBLER SURGICAL CORP.HDK2021-01-04
00190660157197Ambler SurgicalAMBLER SURGICAL CORP.HDK2021-01-04
04046826070595MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHDK2020-09-24
04046826070618MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHDK2020-09-24
04046955086597AESCULAPAESCULAP, INC.HDK2020-05-06
04038653042470AESCULAPAesculap AGHDK2020-04-20
04038653042487AESCULAPAesculap AGHDK2020-04-20
H8343021900Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDK2018-09-18
H8343021950Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDK2018-09-18
24026704514933PILLINGTELEFLEX INCORPORATEDHDK2018-09-15