FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653436217
Brand
AESCULAP
Company
Aesculap AG
Model
DF387R
Catalog number
DF387R
Device description
Dental Punch - Parts perforated disc for DF392R, non-sterile, reusable
Published
2020-05-21
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
EJGFORCEPS, RUBBER DAM CLAMP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJGForceps, Rubber Dam ClampDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653436217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653436217040386534362174038653436217

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument containment holder, reusableA device intended to be used to safely contain a delicate or sharp hand-held, manual, surgical instrument(s) [e.g., needle, scalpel, scissors] during surgery, to avoid damage to the instrument, and/or or for temporary storage (e.g., to enable easy transfer/handling of the instrument at reduced risk of injury). It is available in various forms (e.g., rack, telescopic tube, magnetic mat), may be attached to a surgical drape, and may be used for subsequent sterilization of the instrument(s); it is not a numbered tray and is not intended for counting of sharps. 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
08800019151012BL Clamp B& L Biotech, inc.EJG2025-07-18
08800019151029BL Clamp B& L Biotech, inc.EJG2025-07-18
08800019151036BL Clamp B& L Biotech, inc.EJG2025-07-18
08800019151043BL Clamp B& L Biotech, inc.EJG2025-07-18
08800019151050BL Clamp B& L Biotech, inc.EJG2025-07-18
08800019151067BL Clamp B& L Biotech, inc.EJG2025-07-18
07899798207721QuinelatoSchobell Industrial LtdaEJG2025-02-27
00889813063583Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEJG2024-11-30
00348783001488Premier Rubber Dam PunchPREMIER DENTAL PRODUCTS COMPANYEJG2024-08-01
00813677023315PDT, Inc.PDT, INC.EJG2024-06-27
00813677023322PDT, Inc.PDT, INC.EJG2024-06-27
00348783010602Premier Rubber Dam ClampPREMIER DENTAL PRODUCTS COMPANYEJG2024-04-10
D9495000821Bioclear InstrumentBioclear Matrix SystemsEJG2024-04-05
08800075603449OSUNG MNDOSUNG MND Co., Ltd.EJG2024-02-23
08964003163532NivoB. Ali ImpexEJG2024-01-29
08964003163600Doctor NiceB. Ali ImpexEJG2024-01-29
08964003163273NivoB. Ali ImpexEJG2024-01-27
D9495000813Bioclear InstrumentBioclear Matrix SystemsEJG2023-09-11
D9495000811Bioclear InstrumentBioclear Matrix SystemsEJG2023-08-10
05055382843894DentalTIMESCO HEALTHCARE LIMITEDEJG2023-07-06
00840105222866ZOLL DENTALZoll-DentalEJG2023-04-20
07630392900393HysolateDent4You AGEJG2023-02-28
EZPF19010000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJG2022-11-29
EZPF19015000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJG2022-11-29
EZPF19015500HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJG2022-11-29
EZPF19037010HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJG2022-11-29
EZPF19125000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJG2022-11-29
07898506811823QuinelatoSchobell Industrial LtdaEJG2022-10-24
00810060722541Rubber dam forceps Berman Instruments LLCEJG2022-09-21
00810038090429Composi-Tight®GARRISON DENTAL SOLUTIONS, L.L.C.EJG2022-08-31