FDA.reportPublic FDA data

Sutcliffe Boey SS Laser Shield with all holes in one (non glare), refurb.

Primary DI
10697660001965
Brand
Sutcliffe Boey SS Laser Shield with all holes in one (non glare), refurb.
Company
Oculo-Plastik Inc
Model
21-287R
Device description
The Sutcliffe Boey is an instrument to treat cutaneous lesions (freckles, etc) during laser procedures. The holes limit the size of the laser beam and serve to isolate various sizes of the skin's section according to the need. Holes' sizes are: 1mm, 2mm, 3mm, 4mm, 5mm, 6mm, and 7mm.
Published
2019-11-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10697660001965PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1069766000196510697660001965

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter1Millimeter
Lumen/Inner Diameter2Millimeter
Lumen/Inner Diameter3Millimeter
Lumen/Inner Diameter4Millimeter
Lumen/Inner Diameter5Millimeter
Lumen/Inner Diameter6Millimeter
Lumen/Inner Diameter7Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
514-381-3292sales@oculoplastik.com

Regulatory Flags#

DUNS number
257382580
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10697660003617Autoclavable Plastic Sterilisation Tray with mat, large27-10061512019-11-28
10697660003631Autoclavable Plastic Sterilisation Tray with mat27-1006752019-11-28
10697660003686Autoclavable Plastic Sterilisation Tray with mat, medium27-65452019-11-11
10697660003679Autoclavable Plastic Sterilisation Tray with mat, small27-65302019-11-07
10697660002191David-Baker,Stainless Steel Lid Clamp for the Laser, small (non glare)21-3222019-11-18
10697660002207David-Baker,Stainless Steel Lid Clamp for the Laser, small (non glare), refurb.21-322R2019-11-18
10697660002221David-Baker,Stainless Steel Lid Clamp for the Laser, regular (non glare)21-3232019-11-18
10697660002245David-Baker,Stainless Steel Lid Clamp for the Laser, regular (non glare), refurb21-323R2019-11-18
M87221416V95Symblepharon Ring Conformer Large, In Bulk21-416V2016-10-16
10697660001903Sutcliffe SS Shield & Retractor for the Laser (flat) (non glare), refurb .21-275R2019-11-21
10697660001927Sutcliffe SS Shield & Retractor for the Laser (bent) (non glare), refurb.21-276R2019-11-21
10697660001989Laser SWAB SS Tissue Handler And Backstop for Laser (non glare)21-2892019-11-21
10697660001996Laser SWAB SS Tissue Handler And Backstop for Laser (non glare), refurb.21-289R2019-11-21
10697660002023Khan-Jaeger SS Lid Plate for the Laser (non glare), refurb.21-292R2019-11-21
10697660002047Jaeger SS Lid Plate for the Laser (non glare), refurb.21-295R2019-11-21
10697660003297Plastic Jaeger lid plates, t-yellow more concave model with small & medium ends23-293Y2019-11-25
10697660003310Plastic Jaeger lid plates, t-yellow flater model with medium & large ends23-295Y2019-11-25
10697660003334Desmarres, Autoclavable plastic retractor t-yellow23-311Y2019-11-25
10697660003341Desmarres, Autoclavable plastic retractor t-yellow23-315Y2019-11-25
10697660003433Castroviejo Suturing Forceps (0.3 mm)25-1032019-11-21

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