FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653242825
Brand
AESCULAP
Company
Aesculap AG
Model
DE159R
Catalog number
DE159R
Device description
HOLLENBACK Carving Wax Instrument, 7" (175 mm), double ended, ergonomic handle, peek handle, Fig. 3, green
Published
2020-06-17
Public version status
Update
Distribution status
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
EIYINSTRUMENT, FILLING, PLASTIC, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIYInstrument, Filling, Plastic, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653242825PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653242825040386532428254038653242825

GMDN Terms#

Term, Definition table
TermDefinition
Dental spatula, reusableA hand-held manual dental device used to manipulate filling materials in the plastic state. It is typically made of stainless steel with a small, flat, blunt blade (no sharp edges) at one end, or it may be double-ended. 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
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
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
00817169029281Joy by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEIY2026-03-05
00840018672628Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-11
00840018667167Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-10
00840018667242Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-10
00840018667464Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-10
00840018671768Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-10
00840018671775Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-10
00840018665675Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-09
00840018665804Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-09
00840018665811Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-09
00840018666047Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-09
00840018666085Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-09
00840018666993Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-09
00840018663381Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-04
00840018663626Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-02-04
00840018663190Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-01-29
00840018663213Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-01-29
00840018661622Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-01-28
00840018661639Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-01-28
07649988629341OdneFill Tips 25mmOdne AGEIY2025-09-03
05010058178083InstrapacROBINSON HEALTHCARE LIMITEDEIY2025-06-23
05010058178694InstrapacROBINSON HEALTHCARE LIMITEDEIY2025-06-19
00303620001434Septodont Multi-Use DispenserSEPTODONT SAS SPECIALITES SEPTODONTEIY2025-05-29
00766054002987Turbo-CRESSENTIAL DENTAL SYSTEMS, INC.EIY2025-04-04
00889813066898Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEIY2025-03-12
00889813066904Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEIY2025-03-12
00889813066911Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEIY2025-03-12
00889813066928Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEIY2025-03-12
00889813066935Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEIY2025-03-12
00889813066942Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEIY2025-03-12