FDA.reportPublic FDA data

AESCULAP

Primary DI
04046963611538
Brand
AESCULAP
Company
Aesculap AG
Model
XG126R
Catalog number
XG126R
Device description
APPLYING FORCEPS FOR HSI-CLIP-MEDIUM
Published
2020-08-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDOApplier, surgical, clip

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDOApplier, Surgical, ClipGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046963611538PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046963611538040469636115384046963611538

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. 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
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 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
04038653109999AESCULAPND118RND118R2020-05-08
04038653110018AESCULAPND121RND121R2020-05-08
04038653110056AESCULAPND125RND125R2020-05-06
04038653201303PROCARTFR600RFR600R2020-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD32153690Surgical DirectSurgical Direct, Inc.GDO2026-08-03
B382SD5715420Surgical DirectSurgical Direct, Inc.GDO2026-08-03
00198506093395ELMED INCORPORATEDELMED INCORPORATEDGDO2026-07-28
08800042706166Artisential Clip Applier LargeLIVSMEDGDO2026-07-10
08800042706173Artisential Clip Applier LargeLIVSMEDGDO2026-07-10
04717480902064InnoClipTAIWAN SURGICAL CORPORATIONGDO2026-06-05
04717480902101InnoClipTAIWAN SURGICAL CORPORATIONGDO2026-06-05
04717480902118InnoClipTAIWAN SURGICAL CORPORATIONGDO2026-06-05
04717480902149InnoClipTAIWAN SURGICAL CORPORATIONGDO2026-06-05
04717480902170InnoClipTAIWAN SURGICAL CORPORATIONGDO2026-06-05
04717480902217InnoClipTAIWAN SURGICAL CORPORATIONGDO2026-06-05
04717480902293InnoClipTAIWAN SURGICAL CORPORATIONGDO2026-06-05
08800042706111Artisential Clip Applier LargeLIVSMEDGDO2026-06-05
08800042706128Artisential Clip Applier LargeLIVSMEDGDO2026-06-05
08800042706135Artisential Clip Applier LargeLIVSMEDGDO2026-06-05
08800042706142Artisential Clip Applier LargeLIVSMEDGDO2026-06-05
08800042700065Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042700904Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042700911Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042700928Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042701369Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042701376Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042701390Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042701406Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702878Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702885Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702892Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702908Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702915Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702922Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29