FDA.report

REVCON

Primary DI
00850041704128
Brand
REVCON
Company
Voom Medical Devices, Inc
Model
VHA01000
Catalog number
VHA01000
Device description
Beaver Handle
Published
2023-04-05
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
HWCScrew, Fixation, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions

SubmissionSupplement
K223392000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K223392000REVCON (TM) Screw SystemVoom Medical Devices, Inc.2023-02-28HWC

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850041704128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850041704128008500417041288500417041280850041704128

GMDN Terms

TermDefinition
Scalpel handle, reusableA device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
844-372-5849info@voomdevices.com

Regulatory Flags

DUNS number
080898988
Device count
1
DM exempt
false
Premarket exempt
false
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
00850041704012Voom Medical REVCONTM Screw SystemRSA4046-SRSA4046-S2025-03-01
00850041704029Voom Medical REVCONTM Screw SystemRSA4048-SRSA4048-S2025-03-01
00850041704531Voom Medical REVCONTM Screw SystemRSA4050-SRSA4050-S2025-03-01
00850041704548Voom Medical REVCONTM Screw SystemRSA4052-SRSA4052-S2025-03-01
00850041704555Voom Medical REVCONTM Screw SystemRSA4054-SRSA4054-S2025-03-01
00850041704562Voom Medical REVCONTM Screw SystemRSA4056-SRSA4056-S2025-03-01
00850041704579Voom Medical REVCONTM Screw SystemRSA4058-SRSA4058-S2025-03-01
00850041704586Voom Medical REVCONTM Screw SystemRSA4060-SRSA4060-S2025-03-01
00850041704593Voom Medical REVCONTM Screw SystemRSN3020-SRSN3020-S2025-03-01
00850041704609Voom Medical REVCONTM Screw SystemRSN3022-SRSN3022-S2025-03-01
00850041704616Voom Medical REVCONTM Screw SystemRSN3024-SRSN3024-S2025-03-01
00850041704623Voom Medical REVCONTM Screw SystemRSN3026-SRSN3026-S2025-03-01
00850041704630Voom Medical REVCONTM Screw SystemRSN3028-SRSN3028-S2025-03-01
00850041704647Voom Medical REVCONTM Screw SystemRSN3030-SRSN3030-S2025-03-01
00850041704654Voom Medical REVCONTM Screw SystemRSN3036-SRSN3036-S2025-03-01
00850041704661Voom Medical REVCONTM Screw SystemRSN3038-SRSN3038-S2025-03-01
00850041704678Voom Medical REVCONTM Screw SystemRSN3040-SRSN3040-S2025-03-01
00850041704685Voom Medical REVCONTM Screw SystemRSN3042-SRSN3042-S2025-03-01
00850041704692Voom Medical REVCONTM Screw SystemRSN3044-SRSN3044-S2025-03-01
00850041704708Voom Medical REVCONTM Screw SystemRSN3046-SRSN3046-S2025-03-01

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