FDA.reportPublic FDA data

ERGOPLANT

Primary DI
04046963148065
Brand
ERGOPLANT
Company
Aesculap AG
Model
DX303R
Catalog number
DX303R
Device description
COOLEY ERGOPLANT Micro Forceps, 7", (180 mm), toothing COOLEY, non-sterile, reusable
Published
2020-04-23
Public version status
New
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
EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMGForceps, Tooth Extractor, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046963148065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046963148065040469631480654046963148065

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, tweezers-like, reusableA hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. 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
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
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
G149TBSB7300TBS BASICSACME ENTERPRISE.EMG2026-05-22
G14933001F07TBS DentalACME ENTERPRISE.EMG2026-03-02
G14933002F08TBS DentalACME ENTERPRISE.EMG2026-03-02
G14933010F07TBS DentalACME ENTERPRISE.EMG2026-03-02
G14933011F08TBS DentalACME ENTERPRISE.EMG2026-03-02
G14933012F09TBS DentalACME ENTERPRISE.EMG2026-03-02
G14933020F08TBS DentalACME ENTERPRISE.EMG2026-03-02
G14933021F09TBS DentalACME ENTERPRISE.EMG2026-03-02
00840018672680Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMG2026-02-11
00840018672697Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMG2026-02-11
00840018672703Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMG2026-02-11
00840018672710Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMG2026-02-11
00840018672727Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMG2026-02-11
00840018672734Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMG2026-02-11
00840018672741Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMG2026-02-11
00840018672758Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMG2026-02-11
00840018672765Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMG2026-02-11
00840018672772Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMG2026-02-11
00840018672789Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMG2026-02-11
00840018672796Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMG2026-02-11
00840018665453Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMG2026-02-04
00840018665613Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMG2026-02-04
00840018665620Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMG2026-02-04
00840018665637Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMG2026-02-04
D928100600962DLC0EXTRACTION FORCEPS #962 UPPER DLCW.H. Holden, Inc.EMG2026-01-06
D9288311120CROWN REMOVER - BAUERW.H. Holden, Inc.EMG2026-01-05
00841336100466Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMG2025-11-11
00841336100657Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMG2025-11-11
00841336100664Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMG2025-11-11
00841336100671Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMG2025-11-11