FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653338252
Brand
AESCULAP
Company
Aesculap AG
Model
BA222
Catalog number
BA222
Device description
Disposable Scalpel, polymer handle, Fig. 22, carbon steel, sterile, disposable, package of 10 pieces
Published
2020-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDXSCALPEL, ONE-PIECE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDXScalpel, One-PieceGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653019656PrimaryGS10
04038653338252Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653019656040386530196564038653019656
04038653338252040386533382524038653338252

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel, single-useA hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
315018218
Device count
10
DM exempt
false
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04038653033997AESCULAPDC230RDC230R2020-06-17
04038653034321AESCULAPDE112RDE112R2020-06-17
04038653034369AESCULAPDE116RDE116R2020-06-17
04038653034376AESCULAPDE117RDE117R2020-06-17
04038653034406AESCULAPDE120RDE120R2020-06-17
04038653034901AESCULAPDE676RDE676R2020-06-17
04046963116194S4 CERVICALFW028UFW028U2020-08-24
04046963794248ELAN 4GA768GA7682020-04-24
04046963935184HI-LINE XXSGE813SUGE813SU2020-04-24
04046963935191HI-LINE XXSGE814SUGE814SU2020-04-24
04046963966362ELAN 4GA767GA7672020-04-24
04046964054907ELAN 4GA715RGA715R2020-04-24
04046964076664AESCULAPGE812SUGE812SU2020-04-24
04046964526213ECCOSGB068RGB068R2020-04-24
04038653177035AESCULAPOG963ROG963R2016-09-23
04038653242962AESCULAPDF262RDF262R2020-06-17
04038653339563AESCULAPJG901JG9012025-03-22
04038653345038AESCULAPJG910JG9102020-05-20
04038653038244AESCULAPDP511RDP511R2020-06-17
04038653038251AESCULAPDP512RDP512R2020-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850069257030LumohsNANO SURGICAL, INCGDX2026-02-20
36945630141820STERiLANCESterilance Medical (Suzhou) Inc.GDX2026-02-05
00850057092998HexaHexa DentalGDX2026-01-21
36945630137588index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
36945630137595index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
36945630137601index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
36945630137618index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
36945630139063index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
36945630139070index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
00194613018825MSI Precision Specialty InstrumentsMed Saver, Inc.GDX2025-08-01
00642356001425Mastel Precision Surgical Instruments, Inc.Mastel Precision Surgical Instruments, Inc.GDX2025-07-08
00642356001432Mastel Precision Surgical Instruments, Inc.Mastel Precision Surgical Instruments, Inc.GDX2025-07-08
00642356001449Mastel Precision Surgical Instruments, Inc.Mastel Precision Surgical Instruments, Inc.GDX2025-07-08
00810111224482Scalpel Treace Medical Concepts, Inc.GDX2025-05-06
00810111224543Scalpel Treace Medical Concepts, Inc.GDX2025-03-25
36945630135805BardSterilance Medical (Suzhou) Inc.GDX2025-03-21
06945630114083BardSterilance Medical (Suzhou) Inc.GDX2025-02-28
05063043035045Swann Morton Ltd.SWANN-MORTON LIMITEDGDX2024-12-27
05063043036042Swann Morton Ltd.SWANN-MORTON LIMITEDGDX2024-12-27
20197344025197MEDLINEMEDLINE INDUSTRIES, INC.GDX2024-12-24
20197344025203MEDLINEMEDLINE INDUSTRIES, INC.GDX2024-12-24
20197344025210MEDLINEMEDLINE INDUSTRIES, INC.GDX2024-12-24
28902895129216KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
28902895129223KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
28902895129230KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
28902895129247KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
28902895129285KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
28902895129377KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
28902895148095KIATOADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
28902895148101KIATOADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09