FDA.reportPublic FDA data

A-SPACE SIBD

Primary DI
04046964275395
Brand
A-SPACE SIBD
Company
Aesculap AG
Model
ME641R
Catalog number
ME641R
Device description
A-SPACE SIBD Bone Curette, 60 °, reverse angled, sharp, 5,2 x 7,3 mm, non-sterile, reusable
Published
2020-04-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTFCURETTE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTFCuretteGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964275395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964275395040469642753954046964275395

GMDN Terms#

Term, Definition table
TermDefinition
Bone curette, reusableA manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(888)229-3002setworld_orders@aesculap.com
+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
10705034579689N/AMedos International SàrlHTF2026-09-26
10705034579696N/AMedos International SàrlHTF2026-09-26
10705034579702N/AMedos International SàrlHTF2026-09-26
00810238290070PRINCETONPrinceton Medical Group, Inc.HTF2026-09-22
00850088713763PRINCETONPrinceton Medical Group, Inc.HTF2026-09-22
10705034579313N/AMedos International SàrlHTF2026-08-26
10705034579320N/AMedos International SàrlHTF2026-08-26
00850088713589PRINCETONPrinceton Medical Group, Inc.HTF2026-08-25
00190776419646MillenniumAvalign Technologies, Inc.HTF2026-08-23
00190776419653MillenniumAvalign Technologies, Inc.HTF2026-08-23
00190776426408MillenniumAvalign Technologies, Inc.HTF2026-08-18
00850088713435PRINCETONPrinceton Medical Group, Inc.HTF2026-08-14
00850088713442PRINCETONPrinceton Medical Group, Inc.HTF2026-08-14
00190776422240MillenniumAvalign Technologies, Inc.HTF2026-07-31
00190776422400MillenniumAvalign Technologies, Inc.HTF2026-07-31
00190776422417MillenniumAvalign Technologies, Inc.HTF2026-07-31
00190776422424MillenniumAvalign Technologies, Inc.HTF2026-07-31
00190776422509MillenniumAvalign Technologies, Inc.HTF2026-07-31
00190776422592MillenniumAvalign Technologies, Inc.HTF2026-07-31
00810168190464NAPACIFIC INSTRUMENTS, INC.HTF2026-07-06
B803PS0099100A0ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS00991080ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0099108A0ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS00991090ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0099109A0ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS00991100ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0099110A0ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0395900ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS03959000ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS039590000ORTHOMEDORTHO-MED, INC.HTF2026-06-26