FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653139385
Brand
AESCULAP
Company
Aesculap AG
Model
BJ501R
Catalog number
BJ501R
Device description
"PHANEUF Hysterectomy Forceps, curved, 8"", (205 mm), toothed (1x2), non-sterile, reusable"
Published
2020-04-21
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
HGCCLAMP, UTERINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGCClamp, UterineObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653139385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653139385040386531393854038653139385

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, reusableA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

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
00850083275167Intrace USAPILOTIS TECH LLCHGC2026-07-03
00850083275327Intrace USAPILOTIS TECH LLCHGC2026-07-03
00850083275389Intrace USAPILOTIS TECH LLCHGC2026-07-03
00850083275396Intrace USAPILOTIS TECH LLCHGC2026-07-03
00850083275402Intrace USAPILOTIS TECH LLCHGC2026-07-03
00850083275419Intrace USAPILOTIS TECH LLCHGC2026-07-03
00850083275426Intrace USAPILOTIS TECH LLCHGC2026-07-03
00190776421625MillenniumAvalign Technologies, Inc.HGC2026-06-23
00190776410698MillenniumAvalign Technologies, Inc.HGC2025-09-12
00190776405311MillenniumAvalign Technologies, Inc.HGC2025-07-15
00190776399818MillenniumAvalign Technologies, Inc.HGC2025-06-02
G586OB2791320Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB2792320Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300700Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300710Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300720Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300730Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300740Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300750Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300760Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300770Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300780Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300790Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300820Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300830Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300860Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300910Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300920Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300930Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300940Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18