FDA.reportPublic FDA data

Putty Applicator Gun

Primary DI
00850391007269
Brand
Putty Applicator Gun
Company
ABYRX, INC.
Model
OS-APP
Published
2023-03-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850391007269PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850391007269008503910072698503910072690850391007269

Regulatory Flags#

DUNS number
078818942
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850391007245Montage Settable Bone PuttyMON-BVF-10012023-11-16
00850391007252Montage Settable Bone PuttyMON-BVF-16042023-11-16
00850391007306Montage Flowable Settable Bone PasteMON-BVF-1501FL2023-11-16
00850391007313Montage Flowable Settable Bone PasteMON-BVF-1501FL2023-11-16
00850391007276Putty Applicator AccessoryOS-APP2023-03-24
00850391007290Montage Flowable Settable Bone PasteMON-BVF-1501FL2023-11-16
00850391007320Montage Flowable Settable Bone PasteMON-BVF-1501FL2023-11-16
00850391007023Hemasorb 2.0 gram with SpatulaOS-2012017-01-24
00850391007139Hemasorb 1.0 gram with SpatulaOS-1012017-02-07
00850391007016Montage XT 5ccOS-MON-1001XT2025-04-07
00850391007221Montage Flowable 8ccOS-MON-1501FL2021-02-12
00850391007030Hemasorb 2.0 gram OS-201NS2016-11-16
00850391007054Hemasorb ApplyOSA-3512016-11-03
00850391007450Permatage 10ccOS-PER-20012025-05-21
00850391007443Abyrx Spatula Stand AloneOS-SPA2025-04-08
00850391007436Montage CT 7ccOS-MON-1401CT2025-04-07
00850391007238Permatage 5ccOS-PER-10012023-10-24
00850391007177Montage 2cc MultipackOS-MON-16042017-04-19
00850391007337UNM Montage Flowable Tips (3x)900-MFL2022-08-25
00850391007344UNM Montage Flowable Dispenser900-MFL2022-08-25