FDA.reportPublic FDA data

SurgiLock

Primary DI
00850047863010
Brand
SurgiLock
Company
Medicalock Corporation
Model
SLS1016
Catalog number
SLS1016
Device description
Safety Instrument Platform, 10" X 16", Sterile
Published
2024-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PUIDrape, Surgical, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850047863027PrimaryGS10
00850047863010Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850047863027008500478630278500478630270850047863027
00850047863010008500478630108500478630100850047863010

GMDN Terms#

Term, Definition table
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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6084302475jodie@medicalock.com

Regulatory Flags#

DUNS number
118863171
Device count
15
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850047863294SurgiLockLateral Thoracic KitSLFLTK2024-07-30
00850047863300SurgiLockGeneral Surgical Positioning KitSLFSHTPSPK2024-07-30
00850047863225SurgiLock"59"" Strap Pad"SLFPE59082024-07-30
00850047863621SurgiLockHeel Positioner SLFHEEL47K2025-12-01
00850047863317SurgiLockJelly Wrap Positioning Kit SLFJW1226K2024-07-30
00850047863515SurgiLock"20"" x 36"" Torso Pad"SLFPE20362025-03-27
00850047863454SurgiLockRobotics Positioning KitSLFSHTPJWK2025-02-11
00850047863287SurgiLock"20"" x 24"" Torso Pad (one side)"SLFP1E20242024-10-10
00850047863188SurgiLock"8"" x 10"" Pad"SLFPE08102024-10-10
00850047863218SurgiLock"24"" x 6"" Pad"SLFPE24062024-10-10
00850047863133Dentistry LockDentistry Lock PadDLP07552024-08-05
00850047863119SurgiLockSL10072024-07-30
00850047863102SurgiLockSL10072024-07-30
00850047863157SurgiLock3 in 1 Head PositionerSLFHPE312024-07-30
00850047863195SurgiLock"20"" x 24"" Torso Pad"SLFPE20242024-07-30
00850047863201SurgiLock"20"" x 29"" Torso Pad"SLFPE20292024-07-30
00850047863232SurgiLockTapered Leg PadSLFTLPE32142024-07-30
00850047863249SurgiLockStandard Head PositionerSLFHPES2024-07-30
00850047863263SurgiLockTrendelenburg Head PositionerSLFHPET2024-07-30
00850047863324SurgiLockTorso & Head Positioning KitSLFSHTPK2024-07-30

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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20193489029939MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-17
20193489029953MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-07-17
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30680651501272HalyardO&M HALYARD, INC.PUI2026-06-08
30680651501289HalyardO&M HALYARD, INC.PUI2026-06-08
30680651501296HalyardO&M HALYARD, INC.PUI2026-06-08
30680651501302HalyardO&M HALYARD, INC.PUI2026-06-08
16931918100876AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918102450AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104201AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
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16931918104645AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
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16931918104935AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918105239AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918106977AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04