DORO® Blade

Primary DI
00425043553205
Brand
DORO® Blade
Company
pro med instruments GmbH, Herstellung und Vertrieb medizinisch technischer Ausrüstung
Model
3116-102
Device description
DORO® Blade Set 152 mm, Black Coated, 5 pcs consisting of: 3116-112 3116-122 3116-132 3116-142 3116-152
Published
2017-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HBLHolder, Head, Neurosurgical (Skull Clamp)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBLHolder, Head, Neurosurgical (Skull Clamp)Neurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001808000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001808000DORO HEADREST SYSTEMPro-Med Instruments GmbH2000-08-04HBL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00425043553205PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00425043553205004250435532054250435532050425043553205

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retractor/retraction system blade, reusableA component of a surgical retraction system or surgical retractor designed to function as a parting edge to separate the margins of a wound/incision during an open surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle because it is available in a variety of lengths and sizes. It is made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
313517922
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
04250435534175DORO LUCENT® iMRI Transfer Collision Indicator 4003.416 2020-11-19

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Primary DI, Brand, Company table
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