FDA.report

Avalign

Primary DI
00190776244705
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM37-2120
Device description
Jansen Bone Ronguer, straight,
Published
2023-09-28
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
00190776244705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776244705001907762447051907762447050190776244705

GMDN Terms

TermDefinition
Orthopaedic joint/limb rongeurA hand-held manual surgical instrument designed to remove bone during an orthopaedic intervention of the limbs/joints; it is not primarily intended for nasal, spinal, or cranial use and is not a dedicated rib rongeur. It is a heavy-duty metallic instrument that has a forceps- or pliers-like design and terminates at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. 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

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00190776418267Millennium72-24026202026-03-23

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04052536018314tezoUlrich GmbH & Co. KGHTX2026-03-16
04052536018321tezoUlrich GmbH & Co. KGHTX2026-03-16
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04058749055276NAFehling Instruments GmbH & Co. KGHTX2026-03-05
04058749097238NAFehling Instruments GmbH & Co. KGHTX2026-03-05
B382SD9228132130Surgical DirectSurgical Direct, Inc.HTX2026-02-17
B382SD922813214Surgical DirectSurgical Direct, Inc.HTX2026-02-17
B382SD62240190Surgical DirectSurgical Direct, Inc.HTX2026-02-10
B382SD62241190Surgical DirectSurgical Direct, Inc.HTX2026-02-10
B382SD91931609Surgical DirectSurgical Direct, Inc.HTX2026-02-10
B382SD62003250Surgical DirectSurgical Direct, Inc.HTX2026-02-09
B382SD923811300Surgical DirectSurgical Direct, Inc.HTX2026-02-09
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