FDA.report

Avalign

Primary DI
00190776044763
Brand
Avalign
Company
AVALIGN TECHNOLOGIES, INC.
Model
VM37-2117
Device description
Lempert Rongeur, curved,
Published
2021-11-03
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
HTXRONGEUR

Product Code Classifications

CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190776044763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776044763001907760447631907760447630190776044763

GMDN Terms

TermDefinition
Craniofacial rongeur, reusableA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (cartilage, sinew) or bone, through a cutting/biting action, during surgery involving the cranium and/or face (e.g., craniotomy, ethmoidectomy, mastoidectomy, rhinoplasty); it is not dedicated to dental surgery. It is typically made of metal and designed to withstand the forces required to bite over tough/hard tissue. 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

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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 DIBrandCompanyProduct codePublished
00810055250189Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810055250202Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450509Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450516Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450547Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450554Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450561Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450578Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450585Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450592Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450608Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450615Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450622Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450639Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450646Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450653Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189450660Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451322Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451339Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451346Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451353Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451360Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451377Surgical DesignSurgical Design, Inc.HTX2026-05-23
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00810189451391Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451407Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451414Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451520Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451544Surgical DesignSurgical Design, Inc.HTX2026-05-23
00810189451551Surgical DesignSurgical Design, Inc.HTX2026-05-23