FDA.report

BOJRAB DISSECTOR, LARGE, ANGLED 90°

Primary DI
00844505009683
Brand
BOJRAB DISSECTOR, LARGE, ANGLED 90°
Company
Grace Medical, Inc.
Model
999-DB5
Device description
BOJRAB DISSECTOR, LARGE, ANGLED 90° 0.5MM x 3.5MM, L 165MM
Published
2018-09-21
Public version status
Update
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
LRCInstrument, Ent Manual Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00844505009683PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00844505009683008445050096838445050096830844505009683

GMDN Terms

TermDefinition
ENT elevatorA hand-held, manually-operated, surgical instrument used to lift, position or pry anatomical structures or surgical material during ear/nose/throat (ENT) surgery. It may be a single or a double-ended device with a blunted blade or hook of various shapes with no cutting edges at the distal working end(s) and a handle positioned centrally or at the proximal end. Its shape and size depends upon the intended use, e.g., a blunt antrum, a rhinology or septum elevator, a strong nasal fracture elevator, or a specially designed ear elevator. It is usually made of high-grade stainless steel. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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
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
00844505010269TITANIUM/FLUOROPLASTIC PISTON409-6002026-02-03
00844505014526GRACE PISTON412-5252026-01-07
00844505014533GRACE PISTON412-5502026-01-07
00844505014540GRACE PISTON412-5752026-01-07
00844505014694SKULL BASE999-SB12025-09-26
00844505014700SKULL BASE999-SB22025-09-26
00844505014717SKULL BASE999-SB52025-09-26
00844505014724SKULL BASE999-SB62025-09-26
00844505014502TITANIUM PISTON461-5752025-09-18
00844505014687GRACE MEDICAL FLUOROPLASTIC PISTON402-5502025-09-18
00844505014489ECLIPSE PISTON467-3502025-08-05
00844505014519TITANIUM PISTON460-5752025-08-05
00844505014564GRACE MEDICAL FLUOROPLASTIC PISTON402-4752025-08-05
00844505014670GRACE MEDICAL FLUOROPLASTIC PISTON402-5752025-08-05
00844505014663OFFSET TITANIUM WILDCAT ALTO6232025-07-17
00844505014649NYTEBYTE650N2025-07-02
00844505014618REUTER BOBBIN VENT TUBE520-6862025-01-31
10844505014585REUTER BOBBIN VENT TUBE520-6812025-01-24
10844505014592REUTER BOBBIN VENT TUBE520-6822025-01-24
10844505014608REUTER BOBBIN VENT TUBE520-6832025-01-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00198506090967ELMED INCORPORATEDELMED INCORPORATEDLRC2026-05-26
00198506090974ELMED INCORPORATEDELMED INCORPORATEDLRC2026-05-26
00198506090981ELMED INCORPORATEDELMED INCORPORATEDLRC2026-05-26
00190776417970MillenniumAvalign Technologies, Inc.LRC2026-03-23
00198506089756ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-23
00198506089657ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-17
00198506089534ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-13
00198506089541ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-13
00198506089558ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-13
00198506089572ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-13
08904461031073OSSEOUS-Ear/Nasal ExtractorEON MEDITECH PRIVATE LIMITEDLRC2026-03-13
08904428798377OSSEOUS-CapsuleEON MEDITECH PRIVATE LIMITEDLRC2026-03-13
00198506088926ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-03
00190776417420MillenniumAvalign Technologies, Inc.LRC2026-02-27
00190776417475MillenniumAvalign Technologies, Inc.LRC2026-02-27
00190776417482MillenniumAvalign Technologies, Inc.LRC2026-02-27
00190776417543MillenniumAvalign Technologies, Inc.LRC2026-02-27
00198506088865ELMED INCORPORATEDELMED INCORPORATEDLRC2026-02-25
00198506088469ELMED INCORPORATEDELMED INCORPORATEDLRC2026-02-23
00198506088544ELMED INCORPORATEDELMED INCORPORATEDLRC2026-02-23
00190776416546MillenniumAvalign Technologies, Inc.LRC2026-02-16
00190776415914MillenniumAvalign Technologies, Inc.LRC2026-02-06
00190776415778MillenniumAvalign Technologies, Inc.LRC2026-02-04
04059453133779Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRC2026-02-02
00198506088346ELMED INCORPORATEDELMED INCORPORATEDLRC2026-01-30
04059453133755Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRC2026-01-29
09348811102638INKAThe Trustee for KAISER FAMILY TRUSTLRC2026-01-28
00190776415495MillenniumAvalign Technologies, Inc.LRC2026-01-27
00198506088070ELMED INCORPORATEDELMED INCORPORATEDLRC2026-01-23
00198506087813ELMED INCORPORATEDELMED INCORPORATEDLRC2026-01-16