FDA.reportPublic FDA data

RESOURCE

Primary DI
04046964859038
Brand
RESOURCE
Company
AESCULAP, INC.
Model
BM017ZR
Catalog number
BM017ZR
Device description
MG TC CRILE-WOOD NDL HLDRSTD SERR 185MM
Published
2020-05-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXKHOLDER, NEEDLE; ORTHOPEDIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXKHolder, Needle; OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964859038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964859038040469648590384046964859038

GMDN Terms#

Term, Definition table
TermDefinition
Needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
082594540
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046964823794AESCULAPMF320MF3202026-04-18
04046964759895VEGAMG985RMG985R2020-10-16
04046964759925VEGAMG982RMG982R2020-10-16
04046964759956VEGAMG981RMG981R2020-10-16
04046964993312AESCULAPMG223RMG223R2026-01-16
04046964993329AESCULAPMG224RMG224R2026-01-16
04046955077069AESCULAPUS137US1372020-08-10
04046955077076AESCULAPUS138US1382020-08-10
04046955066544AESCULAPMG512RMG512R2020-09-26
04046955076550AESCULAPMG065RMG065R2020-09-26
04046955076611AESCULAPMG182RMG182R2020-08-25
04046964759970VEGAMG980RMG980R2020-10-16
04046955919369AESCULAPUS981SUUS981SU2025-10-31
04046955919383AESCULAPUS982SUUS982SU2025-10-31
04046955919406AESCULAPUS983SUUS983SU2025-10-31
04046955920327AESCULAPUS984SUUS984SU2025-10-31
04046955920341AESCULAPUS985SUUS985SU2025-10-31
04046955920365AESCULAPUS986SUUS986SU2025-10-31
04046955920389AESCULAPUS987SUUS987SU2025-10-31
04046955920402AESCULAPUS988SUUS988SU2025-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810158219625PRINCETONPrinceton Medical Group, Inc.HXK2026-04-22
00810158216778PRINCETONPrinceton Medical Group, Inc.HXK2026-04-20
09348811016249INKAThe Trustee for KAISER FAMILY TRUSTHXK2025-11-19
09348811016379INKAThe Trustee for KAISER FAMILY TRUSTHXK2025-11-19
B356DF410180American MedicalsAmerican MedicalsHXK2025-11-10
B7685135310Buxton BioMedicalBuxton Biomedical IncHXK2025-11-03
04052536007899neon3Ulrich GmbH & Co. KGHXK2025-11-03
00810158217454PRINCETONPrinceton Medical Group, Inc.HXK2025-10-08
00810158217461PRINCETONPrinceton Medical Group, Inc.HXK2025-10-08
00840314251268gSourceGSOURCE LLCHXK2025-09-21
10649111488146Sklar InstrumentsSKLAR CORPORATIONHXK2025-05-23
10649111488153Sklar InstrumentsSKLAR CORPORATIONHXK2025-05-23
10649111488139Sklar InstrumentsSKLAR CORPORATIONHXK2025-05-22
10649111488160Sklar InstrumentsSKLAR CORPORATIONHXK2025-05-22
10649111062698Sklar InstrumentsSKLAR CORPORATIONHXK2025-02-11
10649111062957Sklar InstrumentsSKLAR CORPORATIONHXK2025-02-10
10649111063268Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-31
10649111063541Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-31
10649111487798Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-31
10649111487835Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-31
10649111063879Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-28
10649111487897Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-28
10649111064579Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-23
10649111064791Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-23
10649111065439Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-23
10649111487828Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-23
10649111065644Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-22
10649111066344Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-22
10649111488054Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-22
10649111077661Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-21