FDA.reportPublic FDA data

Bur Sterilization Holder

Primary DI
17630055505108
Brand
Bur Sterilization Holder
Company
Bien-Air Surgery SA
Model
1600306
Catalog number
1600306-001
Published
2023-02-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MMOTray, Surgical, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMOTray, Surgical, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17630055505108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1763005550510817630055505108

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument containment holder, reusableA device intended to be used to safely contain a delicate or sharp hand-held, manual, surgical instrument(s) [e.g., needle, scalpel, scissors] during surgery, to avoid damage to the instrument, and/or or for temporary storage (e.g., to enable easy transfer/handling of the instrument at reduced risk of injury). It is available in various forms (e.g., rack, telescopic tube, magnetic mat), may be attached to a surgical drape, and may be used for subsequent sterilization of the instrument(s); it is not a numbered tray and is not intended for counting of sharps. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
481597719
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
27630055509653Long Microsaw Blade 32x0.4mm 15026791502679-0012026-04-21
27630055517672Left Inferior Boarder Osteotomy Blade15027231502723-0012026-04-21
47630055517676Left Inferior Boarder Osteotomy Blade15027231502723-0102026-04-21
27630055509479Short Microsaw Blade 22x0.4mm15026711502671-0012026-04-21
27630055509585Short Microsaw Blade 27x0.4mm15026721502672-0012026-04-21
27630055509592Short Microsaw Blade 32x0.4mm15026731502673-0012026-04-21
27630055509608Short Microsaw Blade 22x0.6mm15026741502674-0012026-04-21
27630055509615Short Microsaw Blade 27x0.6mm15026751502675-0012026-04-21
27630055509622Short Microsaw Blade 32x0.6mm15026761502676-0012026-04-21
27630055509639Long Microsaw Blade 22x0.4mm15026771502677-0012026-04-21
27630055509646Long Microsaw Blade 27x0.4mm15026781502678-0012026-04-21
27630055509660Long Microsaw Blade 22x0.6mm15026801502680-0012026-04-21
27630055509677Long Microsaw Blade 27x0.6mm15026811502681-0012026-04-21
27630055509684Long Microsaw Blade 32x0.6mm15026821502682-0012026-04-21
27630055517641Right Inferior Boarder Osteotomy Blade15027221502722-0012026-04-21
27630055517702Short Oscillating Blade 6x0.4mm15027241502724-0012026-04-21
27630055517733Short Oscillating Blade 9x0.4mm15027251502725-0012026-04-21
27630055517764Long Oscillating Blade 6x0.4mm15027261502726-0012026-04-21
27630055517795Long Oscillating Blade 9x0.4mm15027271502727-0012026-04-21
27630055517825Short Sagittal Blade 6x0.4mm15027431502743-0012026-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14250368861734Tray TTP-VARIACHeinz Kurz GmbHMMO2026-05-21
14250368861741Tray KURZ MeterHeinz Kurz GmbHMMO2026-05-21
14250368861765Tray Cartilage PunchHeinz Kurz GmbHMMO2026-05-21
00757770403929Bausch + LombBausch & Lomb IncorporatedMMO2026-04-30
10889483563441BALLARD™SUNMED, LLCMMO2026-01-12
04250676747204Tray set with flex band and pier pinSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
04250676747211Tray set with flex bandSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
04250676747235Filter modul with 8 x LMSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
04250676747228Tray setSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
04251993600128Filter modul with 8 x LMSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
04251993601927Tray set with flex band and pier pinSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
04251993601934Tray set with flex bandSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
00840217910033Ace Medical CompanyEbner Medical, LLCMMO2025-10-08
00840217910040Ace Medical CompanyEbner Medical, LLCMMO2025-10-08
00840217910057Ace Medical CompanyEbner Medical, LLCMMO2025-10-08
04250676741554Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741561Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741578Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741585Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741592Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741608Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741622Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741639Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741899Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250407778262FENTEXFENTEX medical GmbHMMO2025-02-19
00840217909396Ace Medical CompanyEbner Medical, LLCMMO2024-12-11
00840217909402Ace Medical CompanyEbner Medical, LLCMMO2024-12-11
10198459084775Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMO2024-08-04
40198459084776Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMO2024-08-04
00848253002347InHealth Technologies; Blom-SingerFreudenberg Medical, LLCMMO2023-11-03