FDA.reportPublic FDA data

FEATHERVAC FLAT RIBBON STAPES SEAT

Primary DI
10844505012765
Brand
FEATHERVAC FLAT RIBBON STAPES SEAT
Company
Grace Medical, Inc.
Model
906-003
Device description
FEATHERVAC FLAT RIBBON STAPES SEAT 0.014 INCH SLOT WIDTH DISPOSABLE STAINLESS STEEL
Published
2021-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRCInstrument, Ent Manual Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10844505012765PackageGS15In Commercial Distribution
00844505012768PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084450501276510844505012765
00844505012768008445050127688445050127680844505012768

GMDN Terms#

Term, Definition table
TermDefinition
Ossicular prosthesis introducer tipA sterile surgical instrument intended to be fitted to an ossicular prosthesis introducer handpiece for suction-lifting/manipulation of an ossicular prosthesis during implantation. It typically consists of a piece of metal tubing with a distal end designed to house a specific ossicular prosthesis. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)472-2363info@gracemedical.com

Regulatory Flags#

DUNS number
030849173
Device count
1
DM exempt
true
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00844505014762BONE WAX APPLICATOR900-0012026-08-27
00844505012508Cartilage MACROTOME Handle990-1032021-10-29
00844505012515Cartilage MACROTOME Module990-1042021-10-29
00844505012522Cartilage MACROTOME Tissue Support990-1062021-10-29
00844505007139CARTILAGE MICROTOME990-0012018-09-21
00844505009010CARTILAGE MICROTOME MODULE990-0042018-09-21
00844505010399CARTILAGE MICROTOME HANDLE990-0032018-09-21
00844505010405TISSUE SUPPORT DIAL990-0062018-09-21
00844505014786FEATHERVAC, ECLIPSE906-1022026-08-18
00844505014793FEATHERVAC, ECLIPSE FLAT RIBBON906-1032026-08-18
00844505014625HOUGH FLAP KNIFE999-2042026-03-27
00844505014632THOMASSIN DISSECTOR999-2052026-03-27
00844505010269TITANIUM/FLUOROPLASTIC PISTON409-6002026-02-03
00844505014526GRACE PISTON412-5252026-01-07
00844505014533GRACE PISTON412-5502026-01-07
00844505014540GRACE PISTON412-5752026-01-07
00844505012249EndoEar™ ENDOSCOPE, 3MM X 150MM, 0 DEG.EE-03002019-12-05
00844505012256EndoEar™ ENDOSCOPE, 3MM X 150MM, 30 DEG.EE-03302019-12-05
00844505012263EndoEar™ ENDOSCOPE, 3MM X 150MM, 45 DEG.EE-03452019-12-05
00844505012270EndoEar™ ENDOSCOPE, 3MM X 150MM, 70 DEG.EE-03702019-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776432263MillenniumAvalign Technologies, Inc.LRC2026-09-24
00190776432270MillenniumAvalign Technologies, Inc.LRC2026-09-24
00190776431440MillenniumAvalign Technologies, Inc.LRC2026-09-22
00190776432140MillenniumAvalign Technologies, Inc.LRC2026-09-22
00190776428020MillenniumAvalign Technologies, Inc.LRC2026-08-27
00190776428174MillenniumAvalign Technologies, Inc.LRC2026-08-27
00844505014762BONE WAX APPLICATORGrace Medical, Inc.LRC2026-08-27
00190776427566MillenniumAvalign Technologies, Inc.LRC2026-08-26
04054462913633evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913732evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913763evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913794evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913824evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913831evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913855evonosevonos GmbH & Co. KGLRC2026-08-25
04054462913893evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914005evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914012evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914036evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914067evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914074evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914081evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914098evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914104evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914111evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914142evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914203evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914234evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914241evonosevonos GmbH & Co. KGLRC2026-08-25
04054462914258evonosevonos GmbH & Co. KGLRC2026-08-25