FDA.report

Instrapac

Primary DI
05010058183162
Brand
Instrapac
Company
ROBINSON HEALTHCARE LIMITED
Model
8316
Catalog number
8316
Device description
Instrapac Minor Operations Pack - Dermatology X 20
Published
2025-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
PYBMinor Surgical Procedures Tray

Product Code Classifications

CodeDeviceSpecialtyClass
PYBMinor Surgical Procedures TrayGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05010058183162PackageGS120In Commercial Distribution
05010058083165PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05010058183162050100581831625010058183162
05010058083165050100580831655010058083165

GMDN Terms

TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep dry and keep out of direct sunlight

Sterilization Methods

Method

Contacts

PhoneEmail
+441909735502ASKVCI@vernacare.com

Regulatory Flags

DUNS number
237799775
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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05010058178939Instrapac789378932025-05-22
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05010058182370Instrapac823782372025-05-22
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05010058184992Instrapac849984992025-05-22
05010058184343Instrapac843484342025-12-16
05010058178885Instrapac788878882025-09-11
05010058179509Instrapac795079502025-09-11
05010058179660Instrapac796679662025-09-11
05010058180963Instrapac809680962025-09-11
05010058181977Instrapac819781972025-09-11
05010058182554Instrapac825582552025-09-11
05010058183605Instrapac836083602025-09-11
05010058184671Instrapac846784672025-09-11
05010058177840Instrapac778477842025-06-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
20884450376335Merit Medical®Merit Medical Systems, Inc.PYB2026-02-14
10884450116910Merit Medical®Merit Medical Systems, Inc.PYB2025-09-09
10884450096526Merit Medical®Merit Medical Systems, Inc.PYB2025-07-01
05010058177840InstrapacROBINSON HEALTHCARE LIMITEDPYB2025-06-25
05010058178465InstrapacROBINSON HEALTHCARE LIMITEDPYB2025-06-23
05010058178861InstrapacROBINSON HEALTHCARE LIMITEDPYB2025-06-23
05010058179752InstrapacROBINSON HEALTHCARE LIMITEDPYB2025-06-23
05010058180949InstrapacROBINSON HEALTHCARE LIMITEDPYB2025-06-23
05010058181540InstrapacROBINSON HEALTHCARE LIMITEDPYB2025-06-23
05010058181557InstrapacROBINSON HEALTHCARE LIMITEDPYB2025-06-23
05010058181571InstrapacROBINSON HEALTHCARE LIMITEDPYB2025-06-23
05010058181946InstrapacROBINSON HEALTHCARE LIMITEDPYB2025-06-23
05010058182721InstrapacROBINSON HEALTHCARE LIMITEDPYB2025-06-23
05010058182790InstrapacROBINSON HEALTHCARE LIMITEDPYB2025-06-23
05010058182813InstrapacROBINSON HEALTHCARE LIMITEDPYB2025-06-23
05010058182974InstrapacROBINSON HEALTHCARE LIMITEDPYB2025-06-23
05010058183155InstrapacROBINSON HEALTHCARE LIMITEDPYB2025-06-23
05010058183193InstrapacROBINSON HEALTHCARE LIMITEDPYB2025-06-23
05010058184213InstrapacROBINSON HEALTHCARE LIMITEDPYB2025-06-23
05010058184275InstrapacROBINSON HEALTHCARE LIMITEDPYB2025-06-23
05010058185142InstrapacROBINSON HEALTHCARE LIMITEDPYB2025-06-23
05010058180116InstrapacROBINSON HEALTHCARE LIMITEDPYB2025-06-19
05010058184435InstrapacROBINSON HEALTHCARE LIMITEDPYB2025-06-19
05010058181045InstrapacROBINSON HEALTHCARE LIMITEDPYB2025-06-18
05010058182943InstrapacROBINSON HEALTHCARE LIMITEDPYB2025-05-22
05010058184220InstrapacROBINSON HEALTHCARE LIMITEDPYB2025-05-22
05010058184800InstrapacROBINSON HEALTHCARE LIMITEDPYB2025-05-22
05010058184992InstrapacROBINSON HEALTHCARE LIMITEDPYB2025-05-22
05010058178229InstrapacROBINSON HEALTHCARE LIMITEDPYB2025-05-21
05010058178427InstrapacROBINSON HEALTHCARE LIMITEDPYB2025-05-21