FDA.reportPublic FDA data

Bipolar Forceps

Primary DI
04250381889787
Brand
Bipolar Forceps
Company
Spiggle & Theis Medizintechnik GmbH
Model
80-105-19
Catalog number
80-105-19
Device description
Bipolar forceps, NON-STICK, straight, angled tip, tip length 8 mm, 0.5 mm wide, guide pin, 19.5 cm
Published
2019-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101080000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101080000NON STICK BIPOLAR FORCEPS MODEL 07/XXX, BIPOLAR FORCEPS MODEL 08/XXX, MONOPOLAR FORCEPS MODEL 09/XXXEgon Faulhaber Surgical Instruments Pinzetten2010-06-21GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250381889787PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250381889787042503818897874250381889787

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, bipolar, reusableAn invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length19.5Centimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+492206908153p.stockmann@spiggle-theis.com

Regulatory Flags#

DUNS number
332893028
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

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