FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653160587
Brand
AESCULAP
Company
Aesculap AG
Model
FD361R
Catalog number
FD361R
Device description
"Handle, 4 1/8"" (105 mm), round handle"
Published
2020-11-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXYBRACE, DRILL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXYBrace, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653160587PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653160587040386531605874038653160587

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel handle, reusableA device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). 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
315018218
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
04038653434022AESCULAPFT944TFT944T2015-09-24
04046963417468AESCULAPFT942TFT942T2015-09-24
04038653042586AESCULAPET251RET251R2016-09-23
04046964227547AESCULAPGF058BGF058B2016-09-23
04038653148998AESCULAPDO706RDO706R2020-04-21
04038653105878AESCULAPLS059RLS059R2020-04-21
04038653106080AESCULAPLS099RLS099R2020-04-21
04038653034666AESCULAPDE419RDE419R2020-06-17
04038653034697AESCULAPDE422RDE422R2020-06-17
04038653105977AESCULAPLS084RLS084R2022-07-29
04038653199020AESCULAPXG105RXG105R2021-10-15
04038653199006AESCULAPXG103RXG103R2020-08-24
04038653199013AESCULAPXG104RXG104R2020-08-24
04038653460533AESCULAPXG106RXG106R2020-08-24
04046963000431AESCULAPXG107RXG107R2020-08-24
04046963000448AESCULAPXG108RXG108R2020-08-24
04046963611538AESCULAPXG126RXG126R2020-08-24
04038653109999AESCULAPND118RND118R2020-05-08
04038653110018AESCULAPND121RND121R2020-05-08
04038653110056AESCULAPND125RND125R2020-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862605764EPICExactech, Inc.HXY2026-04-28
05055662970593ORTHO SOLUTIONS SUCCESSION AFN SYSTEMORTHO SOLUTIONS HOLDINGS LIMITEDHXY2025-08-14
05055662971293Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2025-06-23
05055662971309Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2025-06-23
05055662971316Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2025-06-23
05055662971323Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2025-06-23
00889024682399PSN TM TIB DRILL GDEZimmer, Inc.HXY2025-01-13
00810027271594Citrelock ACL Tibial Drill Guide, Flat HookAcuitive Technologies, Inc.HXY2024-12-03
00191083044569Meniscus Allograft Transplantation (MAT)Rti Surgical, Inc.HXY2024-10-14
04049197096812RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHXY2024-07-16
04049197096744RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHXY2024-07-15
04026575534678LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGHXY2024-07-11
04026575534739LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGHXY2024-07-11
04049197187848RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHXY2024-06-28
00840183516031BR Surgical, LLCBR Surgical, LLCHXY2024-06-03
00840183516048BR Surgical, LLCBR Surgical, LLCHXY2024-06-03
M73910290060TransFasten-LSF, Offset GuideCAPTIVA SPINE, INC.HXY2024-04-25
M73910290130TransFasten - LSF, Sharp Guide Pin Ø3.2mm x 229mmCAPTIVA SPINE, INC.HXY2024-04-25
M73910290140TransFasten - LSF, Blunt Guide Pin Ø3.2mm x 229mmCAPTIVA SPINE, INC.HXY2024-04-25
M73910290150TransFasten - LSF, Blunt Guide Pin Ø3.2mm x 457mmCAPTIVA SPINE, INC.HXY2024-04-25
M73910290170TransFasten - LSF, Open-Ended Offset GuideCAPTIVA SPINE, INC.HXY2024-04-25
M73910290180TransFasten - LSF, Parallel GuideCAPTIVA SPINE, INC.HXY2024-04-25
05055662969825COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969832COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969849COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969856COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969863COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969870COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
M7392030002104-Hole Drill GuideCAPTIVA SPINE, INC.HXY2024-03-11
08033860019105BIOPSYBELLBIOPSYBELL SRLHXY2024-02-23